Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients

• Status: Not yet recruiting
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

1. Volunteers who have understood and signed the informed consent;

2. Age ≥18 years, gender unlimited;

3. Patients diagnosed with acute severe 2019-nCoV pneumonia:

1. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.

2. Lung involvement confirmed with pulmonary CT scan.

3. At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.

Exclusion Criteria:

1. Viral pneumonia with other viruses besides 2019-nCoV.

2. Patients are not suitable for immunoglobulin therapy.

3. Participation in other studies.

4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.